Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, cardiovascular diseases
Sponsor Federal University of Rio Grande do Sul
Start date August 2008
End date December 2020
Trial size 15105 participants
Trial identifier NCT02320461, 01.06.0010.00

Summary

The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) aims to contribute with relevant information regarding the development and progression of clinical and subclinical chronic diseases, particularly cardiovascular diseases and diabetes. The investigators enrolled 15,105 civil servants from predefined universities or research institutes. Baseline assessment (2008-2010) included detailed interviews and measurements to assess social and biological determinants of health, as well as various clinical and subclinical conditions related to diabetes, cardiovascular diseases and mental health. For the ascertainment of incident events, annual telephone surveillance is being conducted since 2009, and a second visit of interviews and exams is under way (2012-2014). Long-term biological sample storage is provided for sera, plasma, urine and DNA. Baseline data is available for analyses, and collaboration via specific research proposals directed to study investigators is welcome.

This multicenter study is chaired by a steering committee, made up of the coordinators and vice-coordinators of each of the six centers. No individual center coordinates the study. The six institutions listed in the contact details all sponsor the study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Diabetes mellitus (Incident cases)
time frame: 6 years
Myocardial infarction (Incident cases)
time frame: 6 years

Eligibility Criteria

Male or female participants from 35 years up to 74 years old.

Inclusion Criteria: - age 35-74 years, - active or retired employees of the institutions involved or affiliated institutions. Exclusion Criteria: - current or recent (<4 months prior to the first interview) pregnancy, - intention to quit work at the institution in the near future, - severe cognitive or communication impairment and, - if retired, residence outside each center´s corresponding metropolitan area.

Additional Information

Official title Estudo Longitudinal de Saúde do Adulto
Principal investigator Estela M Aquino, MD
Description Full details of the study have been published in the American Journal of Epidemiology (http://aje.oxfordjournals.org/content/early/2012/01/10/aje.kwr294.full) and the International Journal of Epidemiology (http://ije.oxfordjournals.org/content/early/2014/02/27/ije.dyu027.abstract), as listed in the References here. Both articles are available in full text for download without charge.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Federal University of Rio Grande do Sul.